At a Glance
- Tasks: Lead Clinical Quality Assurance activities and drive compliance across Australian clinical programs.
- Company: Join a globally recognised biopharmaceutical organisation making a real impact.
- Benefits: Competitive salary, strong career development, and the chance to shape quality systems.
- Other info: Collaborative culture with opportunities for global exposure and meaningful contributions.
- Why this job: Be a key player in transforming patient outcomes with innovative therapies.
- Qualifications: 5+ years in clinical research and strong knowledge of GCP and regulatory compliance.
The predicted salary is between 160000 - 200000 $ per year.
Evolve Scientific is partnering with an innovative, globally recognised biopharmaceutical organisation to appoint a Senior Manager or Associate Director, Clinical Quality Assurance. This is a rare opportunity to take ownership of Quality Assurance activities across Australian clinical development programs while contributing to cutting-edge therapies that have the potential to transform patient outcomes.
If you're a seasoned Clinical QA professional looking to step into a highly visible leadership role with global exposure, this could be your next career-defining move.
The Opportunity
As the local Clinical Quality Assurance lead, you'll be responsible for driving quality strategy, ensuring GxP compliance, supporting audit and inspection readiness, and partnering closely with Clinical Operations and key stakeholders to embed a culture of quality across clinical programs. You'll have the opportunity to influence quality systems, vendor oversight, risk management and continuous improvement initiatives within a fast-growing, science-driven organisation.
Key Responsibilities
- Lead Clinical QA activities across Australian clinical programs
- Provide expert guidance on GCP, GMP, ICH and regulatory compliance requirements
- Manage deviations, investigations, CAPAs and quality events
- Drive inspection readiness and compliance monitoring activities
- Support and maintain Quality Management System documentation, SOPs and procedures
- Develop risk-based quality management strategies and quality metrics
- Lead vendor qualification, oversight and performance reviews
- Conduct and manage investigator site and vendor audits
- Monitor regulatory developments and implement quality improvements across the business
About You
You'll be a passionate quality leader who thrives in a collaborative and fast-paced environment.
Essential requirements
- Degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences or related discipline
- 5+ years' experience within clinical research, CRO, biotechnology or pharmaceutical environments
- 3+ years' experience in Clinical Quality Assurance, Quality Compliance or Quality Management
- Strong knowledge of ICH-GCP, TGA regulations and clinical quality systems
- Experience managing deviations, investigations, CAPAs and quality oversight activities
- Excellent stakeholder management, communication and influencing skills
- Full Australian working rights
Highly regarded
- Experience supporting regulatory inspections and responses
- Investigator site and vendor audit experience
- Experience within global pharmaceutical or biotechnology organisations
- Oncology clinical trial experience
- Advanced scientific or healthcare qualification
What's On Offer
- Senior leadership opportunity with genuine influence and visibility
- Exposure to global clinical development programs
- Ability to shape and strengthen quality systems and processes
- Collaborative, innovative and high-performing culture
- Strong career development and progression opportunities
- Opportunity to contribute to life-changing therapies and meaningful patient outcomes
Senior Manager, Clinical Quality Assurance in Sydney employer: Evolve Scientific
Join a leading pharmaceutical company in the Southeast suburbs of Melbourne, where you will be part of a dynamic team dedicated to quality and compliance. With a strong focus on employee development and a culture that promotes continuous improvement, this role offers meaningful opportunities for growth in a supportive environment. Enjoy the benefits of full-time hours, a collaborative work culture, and the chance to make a significant impact in the pharmaceutical industry.
